Official Title
A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
Brief Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalationclinical trial to evaluate the safety, tolerability, immunogenicity and immunepersistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.

Detailed Description

Not Provided

Active, not recruiting
SARS-CoV-2

Biological: 20 μg dose of SYS6006

20 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Biological: 30 μg dose of SYS6006

30 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Drug: Placebo

Placebo IM on day 0 and day 21.

Eligibility Criteria

Inclusion Criteria:

1. Age at the time of the first dose of vaccine: 18 to 59 years;

2. Axillary body temperature is less than 37.3 degree centigrade on the day of
enrollment;

3. Based on the medical history and relevant physical examination and laboratory
examination results (normal or abnormal but no clinical significance), the
investigator clinically determined that the patient was in good health;

4. Has independent judgment, and participate voluntarily and sign an informed consent
form.

Exclusion Criteria:

1. Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2
infected persons (nucleic acid test positive) or living abroad within 30 days before
screening;

2. Positive SARS-CoV-2 antibody test;

3. Previous history of allergy to acetaminophen or vaccination(eg, acute allergic
reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);

4. Has a history of COVID-19 vaccination, or have received other inactivated or
recombinant vaccines within 7 days, or received live attenuated vaccines within 14
days,before the first dose;

5. Has a medical history or family history of epilepsy, convulsions, neurological
diseases and psychiatric diseases;

6. Is contraindicative for intramuscular injection,such as: diagnosed thrombocytopenia,
any coagulation disorders, or receiving anticoagulant therapy;

7. Has known or suspected serious disorders judged by the Investigator, including but
not limited to respiratory disorders (pulmonary failure, etc.), liver and kidney
disorders, cardiovascular disorders (cardiac failure, severe hypertension, etc.),
malignant tumors, infections or allergic skin disorders, HIV infection, or in the
acute infection or chronic disease activity period (within 3 days before
vaccination);

8. Has chronic diseases (such as Down syndrome, sickle cell anemia, neurological
disorders and Guillain-Barre syndrome, excluding stably controlled
diabetes/hypertension) that are not suitable for this study at the discretion of the
Investigator;

9. Has known immunocompromised conditions diagnosed in hospital before enrollment, or
functional aspleen or splenectomy caused by any condition;

10. For women of childbearing potential: positive pregnancy test, being in pregnancy or
breastfeeding, or have a pregnancy plan within one year;men: whose spouses is of
childbearing potential and has a pregnancy plan within 1 year;

11. Is participating in other clinical trials or plan to participate in other clinical
trials during the study period;

12. Has received immune enhancement or immunosuppressive therapy within 3 months before
the first dose of vaccine (continuous oral or instillation for more than 14 days);
or received whole blood, plasma and immunoglobulin therapy within one month;

13. Is unlikely to adhere to the study procedures or keep appointments at the discretion
of the investigators;or plan to permanently relocate before the end of study; or
plan to leave the resident location for a long time at the scheduled visit; or has
any other conditions that are inappropriate for participation for this study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 59 Years
Countries
China
Locations

Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu, China

Shulan(hangzhou) Hospital
Hangzhou, Zhejiang, China

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
NCT Number